MAUDE Adverse Event Report: JIANGYIN HUASHI MEDICAL DRIVE; WALKER, MECHANICAL

Model Number 10215RD-1

Device Problem Break (1069)

Patient Problem Vertebral Fracture (4520)

Event Date 04/23/2023

Event Type  Injury  

Event Description

Drive devilbiss healthcare was notified of a complaint regarding a rollator by the end user, who stated that "while sitting at her kitchen table on her rollator, the rear wheel broke, causing her to fall backwards onto the unit." ems transported her to the hospital, where films showed a 20% fracture to her t7 vertebrae.Drive attempted to retrieve the product for investigation, but the end user had already discarded the unit after the incident.Drive will continue to monitor for trends.

• Brand Name: DRIVE
• Type of Device: WALKER, MECHANICAL
• Manufacturer (Section D): JIANGYIN HUASHI MEDICAL; no.589 huashi road; huashi town; jiangyin city, jiangsu ; CH
• MDR Report Key: 17876713
• MDR Text Key: 324988860
• Report Number: 2438477-2023-00131
• Device Sequence Number: 1
• Product Code: ITJ
• UDI-Device Identifier: 00822383100654
• UDI-Public: 00822383100654
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 10215RD-1
• Device Catalogue Number: 10215RD-1
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/05/2023
• Distributor Facility Aware Date: 09/07/2023
• Event Location: Home
• Date Report to Manufacturer: 10/05/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/05/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR
• Patient Sex: Female